Tokyo, Aug. 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058888) titled 'Verification study of the effects of foods containing plant extracts on sleep' on Aug. 27.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Kao Corporation
Condition:
Condition - Not applicable
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To verify the effects of foods containing plant extracts on sleep.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Take foods containing plant extract once a day for 14 days
Interventions/Control_2 - Take placebo once a day for 14 days
Eligibility:
Age-lower limit - 30
years-old
=
Gender - Male and Female
Key inclusion criteria - 1. Healthy male and female aged 30-59
2. Person who work day shifts, 5 days a week with weekends off
3. Person who commute by train and whose main occupation is in an industry other than primary industry or manual labor
4. Person who are dissatisfied or worried about their sleep
5. Person who feel tired when they wake up (3 or more days a week on weekdays) and whose fatigue improves on Saturdays and Sundays.
Key exclusion criteria - 1.Person with a history of serious diseases such as circulatory, cardiovascular, digestive, endocrine diseases, mental illness, or malignant neoplasms.
2.Person with a BMI of 25 or greater, or 18 or less. If participant numbers are low, those with a BMI of 27 or greater, or 18 or less may be accepted.
3.Person with systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg.
4.Person consuming more than 40g of alcohol (about 2 go of sake) daily.
5.Person who smoke cigarettes regularly or occasionally.
6.Person diagnosed with chronic fatigue syndrome.
7.Person who sleep less than 5 hours or more than 7 hours on average on weekdays.
8.Person regularly taking medications that affect sleep or fatigue.
9.Person with significant variations in sleep duration, wake-up, and bedtime.
10.Person planning major life changes (e.g.,higher education, job changes, moving) during the study period.
11.Person experiencing symptoms that affect sleep.
12.Person living with preschool children (under 3 years old) or those needing nighttime care.
13.Pregnant Person, those wishing to become pregnant, or breastfeeding during the study.
14.Person unable to properly evaluate using a Visual Analogue Scale.
15.Person who have difficulty understanding or filling out the questionnaire in Japanese.
16.Person allergic to any ingredients in the test product (excluding 28 specified allergens).
17.Person unable to consume ingredients with unspecified origins due to religious or other reasons.
18.Person already involved in other research or those planning to participate in additional studies during the trial period, or those who have participated in other drug or food trials within the past month.
19.Person deemed inappropriate for participation by the principal investigator.
Target Size - 160
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 08 Month 19 Day
Date of IRB - 2025 Year 08 Month 19 Day
Anticipated trial start date - 2025 Year 08 Month 27 Day
Last follow-up date - 2025 Year 11 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067307
Disclaimer: Curated by HT Syndication.
